Q&A Regulated Product Submissions (RPS)
Oct09

Q&A Regulated Product Submissions (RPS)

Jason Rock, Chief Technical Officer at GlobalSubmit, offered great insight into the topic of Regulated Product Submissions (RPS) or eCTD version 4.0 during a free educational webinar jointly hosted by Cato Research and GlobalSubmit, “Background and Drivers to the eCTD Next Major Version / Regulated Product Submission”, on Thursday, October 4th at 1:00 p.m. EDT.

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Free Educational Webinar: Regulatory Electronic Submissions: eCTD v4 Background and Drivers

Presentation Details: The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time? Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free educational webinar jointly hosted by Cato Research...

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Next RPS Ballot Delayed Until September 2011

The May 2011 ballot date was missed and is now delayed until September 2011. Why was the date missed? In my opinion, we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.

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Comparing XML in RPS, eCTD

Recently, I was providing some training to a GlobalSubmit client and one of the participants asked me about an xml document that was present in a folder along with the sample eCTD that we use for training. The document was called “porp.xml”. I explained that GlobalSubmit’s VALIDATE product can transform eCTD into RPS and when it does, it produces the XML backbone used for RPS, which is called porp.xml. This is a single xml document...

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RPS Ballot Passes, Working Group Now Evaluating Comments

Our posting this time is from Jason Rock, GlobalSubmit CTO and Chair of the HL7 RPS Specification Development Group. The Draft Standard for Trial Use (DSTU) ballot of the Regulated Product Submission Release 2 standard barely passed ballot on Monday January 11th. The ballot passed by two votes with a result of 53 affirmative and 33 negative. Even though the ballot passed, the process is not over. Every comment must be evaluated. This...

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